(100 days)
The BOSTON XO2 Gas Permeable Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, astigmatism, and presbyopia) in aphakic and notaphakic persons with non-diseased eyes.
The lens may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
The lens is also indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
BOSTON XO2 (hexafocon B) Rigid Gas Permeable Contact Lens material is a fluoro silicone acrylate copolymer rigid gas permeable contact lens material. The material is available in blue, ice blue, green, or violet, yellow and red tint. The lenses may contain an ultraviolet light absorber, Uvinul D-49 or MHB. The blue and ice blue tinted lenses contain the color additive D&C Green No. 6; the green tinted lenses contain the color additives D&C Green No. 6 and C.I. Solvent Yellow No. 18; the violet tinted lenses contain the color additive D&C Violet No. 2. the red tinted lenses contain the color additive D&C Red No. 17; and the yellow lenses contain the color additive C.I. Solvent Yellow No.18. All of those color additives are listed in the Code of Federal Regulations (21 CFR 74.3206).
The provided document is a 510(k) summary for a contact lens, not an AI/ML medical device. Therefore, many of the requested categories in the prompt, such as "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Training set sample size," or "Ground truth for training set," are not applicable. I will extract the information that is relevant to the acceptance criteria and the study proving the device meets those criteria based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Outcome Desired | Reported Device Performance (Boston XO2) |
|---|---|---|
| Lens Material Compatibility | No significant changes to lens parameters after 30 cycles with various care regimens. | No significant changes to lens parameters after 30 complete cycles. |
| Total Extractable Substances (ISO 10340:1995(E)) | Total extractable amount should be less than or comparable to the predicate device (Boston XO). | Total amount of material extracted was less than that extracted from Boston XO. |
| Extractable Color Additives and UV Blockers (ISO 10340:1995(E)) | Results should be similar to those obtained from the predicate device (Boston XO). | Results are similar to those obtained when extracting Boston XO. |
| Cytotoxicity (ISO 10993-5) | Material should not induce cytotoxicity. | Material did not induce cytotoxicity (in-vitro assay using L-929 cell monolayer). |
| Ocular Irritation (ISO 10993-10) | Material should be considered a non-irritant. | Material is considered to be a non-irritant (in rabbit ocular tissue). |
| Systemic Toxicity (ISO 10993-11) | Test samples should meet test requirements (e.g., normal observations). | All observations of the mice were normal; test samples meet test requirements. |
| Bioburden and Shelf-Life (ISO 11987:1997) | Average bioburden levels should be within acceptable limits ( |
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.